| Device Classification Name |
Sleeve, Limb, Compressible
|
| 510(k) Number |
K141390 |
| Device Name |
INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
| Applicant |
| Wuhan Landing Medical Hi-Tech, Ltd. |
| 818 Gaoxin Rd. E. Lake High Tech Development Zone |
| Floors 1&2,Units B&C&D Bldg. #B7 Med Equipment Pk |
|
Wuham,
CN
430206
|
|
| Applicant Contact |
YAN LIU |
| Correspondent |
| Wuhan Landing Medical Hi-Tech, Ltd. |
| 818 Gaoxin Rd. E. Lake High Tech Development Zone |
| Floors 1&2,Units B&C&D Bldg. #B7 Med Equipment Pk |
|
Wuham,
CN
430206
|
|
| Correspondent Contact |
YAN LIU |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 05/27/2014 |
| Decision Date | 11/18/2014 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|